NCT01076504

A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer

A Phase II Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC). Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered with each treatment cycle. This trial will be the first clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line treatment of ES SCLC in a U.S. population.

Conditions

• Extensive-Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Amrubicin	30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
DRUG	Carboplatin	AUC=5 IV, Day 1 of each 3-week treatment cycle
DRUG	Pegfilgrastim	6 mg SQ on Day 4 of each 3 week treatment cycle

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-03-01
• Completion: 2015-03-01
• First posted: 2010-02-26
• Last updated: 2016-05-05
• Results posted: 2015-12-10

Locations

20 sites across 1 country: United States